ISO 11137-2:2006
Withdrawn
View Superseded by
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Hardcopy , PDF
04-19-2006
04-09-2025
ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
60
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| AS/NZS ISO 11137.2:2006 | Identical |
| I.S. EN ISO 11137-2:2006 | Equivalent |
| UNE-EN ISO 11137-2:2006 | Identical |
| JIS T 0806-2:2010 | Identical |
| UNE-EN ISO 11137-2:2007 | Identical |
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